ASC-30

-ASC37 demonstrated statistically significant 88% greater relative body weight reduction compared to tirzepatide in the diet-induced obese (DIO) mouse model. -Both ASC37 once-monthly subcutaneous (SQ) formulation and oral formulation will be submitted to the U.S. Food and Drug Administration (FDA) via a biologics license application (BLA). HONG KONG, July 27, 2026 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces that ASC37, a next-generation GLP-1R/GIPR/GCGR[1] triple peptide agonist, demonstrated superior weight loss to tirzepatide in a diet-induced obese (DIO) mouse model. Following 11-day administration of ASC37 and tirzepatide at the same dose of 1 nmol/kg in DIO mice, ASC37 had statistically significant 88% greater relative body weight reduction compared to tirzepatide (Table 1). Furthermore, ASC37 demonstrated up to 41.5% weight loss in a dose-dependent fashion in the DIO mice (Table 1). Table 1. ASC37 demonstrated statistically and significantly more weight loss than tirzepatide in DIO mice following 11-day administration Note: DIO mice: diet-induced obese mice; SQ: subcutaneous; QD: once daily. ASC37 was engineered to have 41 alpha amino acids, which qualifies it as a biologic. The Investigational New Drug (IND) application of both ASC37 once-monthly subcutaneous (SQ) formulation and oral formulation will be submitted in the third quarter of 2026. Biologics license applications (BLAs) for both ASC37 once-monthly SQ formulation and oral formulation will be submitted to the FDA after Phase III completion. ASC35, a next-generation GLP-1R/GIPR dual peptide agonist, also has 41 alpha amino acids and will be submitted as a BLA as well. Compared to retatrutide, another triple peptide agonist, in non-human primate (NHP) studies, ASC37 SQ Self Assembly Lipid Depot (SALD) formulation had an average observed half-life of approximately 17 days compared to 2.5 days for retatrutide. This approximately 7-fold longer half-life for ASC37 confirms once-monthly or less dosing frequency. "Based on these encouraging preclinical data, we believe ASC37 has the potential to be a first-in-class once-monthly SQ triple peptide agonist for people living with severe obesity, also with the added advantage of being submitted under the BLA regulatory process," said Jinzi Jason Wu, Ph.D., Founder, Chairman and CEO of Ascletis. "Qualification of ASC37 as a biologic offers a number of benefits, including longer statutory exclusivity periods and extended protection from government price negotiation compared to small molecules." Under the Inflation Reduction Act, biologics benefit from a longer exemption period of 13 years following FDA approval, instead of nine years for small molecules, before being subject to government price negotiations. There is also no regulatory path for biologics to be compounded by third-party pharmacies. This limits the ability of compounding pharmacies from potentially offering a lower-price version of ASC37 and ASC35. About Ascletis Pharma Inc. Ascletis Pharma Inc. is a fully integrated biotechnology company focused on the development and commercialization of potentially best-in-class and first-in-class therapeutics to treat metabolic diseases. Utilizing its proprietary Artificial Intelligence-assisted Structure-Based Drug Discovery (AISBDD) and Ultra-Long-Acting Platform (ULAP) technologies as well as Peptide Oral Transport ENhancement Technology (POTENT), Ascletis has developed multiple drug candidates in-house, including both small molecules and peptides, such as its lead program, ASC30, a small molecule GLP-1R agonist designed to be administered once daily orally and once monthly to once quarterly subcutaneously as a treatment therapy and a maintenance therapy for chronic weight management; ASC36, an amylin receptor peptide agonist, ASC35, a once-monthly subcutaneously administered GLP-1R/GIPR dual peptide agonist and ASC37, a GLP-1R/GIPR/GCGR triple peptide agonist, ASC39, an eloralintide-like potent and amylin-selective oral small molecule amylin receptor agonist, ASC30_39 FDC, a fixed-dose combination (FDC) of ASC30 (GLP-1 RA) and ASC39 (amylin RA), ASC30_48 FDC, a fixed-dose combination (FDC) of ASC30 (GLP-1 RA) and ASC48 (GIP RA), for chronic weight management. Ascletis is listed on the Hong Kong Stock Exchange (1672.HK). For more information, please visit . Contact： Peter Vozzo ICR Healthcare 443-231-0505 (U.S.) [email protected] Ascletis Pharma Inc. PR and IR Teams +86-181-0650-9129 (China) [email protected] [email protected] SOURCE Ascletis Pharma Inc. 21% more press release views with Request a Demo

-在饮食诱导肥胖(DIO)小鼠模型中，ASC37的减重效果较替尔泊肽相对提升88%，且差异具有统计学显著性。 -ASC37每月一次皮下(SQ)制剂和口服制剂均将通过生物制品许可申请(BLA)路径向美国食品药品监督管理局(FDA)递交上市申报。 香港，2026年7月27日 – 歌礼制药有限公司(香港联交所代码：1672，简称“歌礼”)宣布，新一代GLP-1R/GIPR/GCGR[1]三靶点激动剂多肽ASC37，在饮食诱导肥胖(DIO)小鼠模型中展现出了优于替尔泊肽的减重效果。在DIO小鼠中，以1 nmol/kg的相同剂量给药11天后，ASC37的减重效果较替尔泊肽相对提升88%，且差异具有统计学显著性(表1)。此外，在DIO小鼠中，ASC37实现了高达41.5%的体重下降(表1)，且呈剂量依赖性。 表1. 给药11天后，ASC37在DIO小鼠中的减重效果优于替尔泊肽，且差异具有统计学显著性 注释：DIO小鼠：饮食诱导肥胖小鼠 经精准定向设计，ASC37包含41个α-氨基酸，符合生物制品资格。ASC37每月一次皮下制剂和口服制剂的新药临床试验申请(IND)将于2026年第三季度递交。ASC37每月一次皮下制剂和口服制剂的生物制品许可申请(BLA)将在III期临床完成后向FDA递交。新一代GLP-1R/GIPR双靶点激动剂多肽ASC35同样含有41个α-氨基酸，也将通过生物制品许可申请(BLA)的路径进行上市申报。 与另一款三靶点激动剂多肽retatrutide相比，在非人灵长类动物(NHP)研究中，ASC37皮下自组装脂质储库(SALD)制剂的平均表观半衰期(observed half-life)约为17天，而retatrutide为2.5天。ASC37这一约7倍于retatrutide的半衰期，支持每月一次或更低的给药频率。 吴劲梓博士 歌礼创始人、董事会主席兼首席执行官 基于这些令人鼓舞的临床前数据，我们相信ASC37有望成为用于重度肥胖症患者的同类首创(first-in-class)、每月一次皮下注射三靶点激动剂多肽，并且还具有通过BLA注册路径申报的额外优势。取得生物制品资格为ASC37提供诸多优势，包括与小分子药物相比，享有更长的法定市场独占期以及免受政府价格谈判影响的更长保护期。 根据《通胀削减法案》(Inflation Reduction Act)，生物制品在FDA批准后享有长达13年的价格谈判豁免期(而不是小分子药物的9年)，而后才受政府价格谈判约束。此外，监管路径不允许第三方药房对生物制品进行仿制配制(compound)。这限制了配药房(compounding pharmacy)提供低价版ASC37和ASC35的可能性。 [1]GLP-1R：胰高血糖素样肽-1受体，GIPR：葡萄糖依赖性促胰岛素多肽受体，GCGR：胰高血糖素受体 关于歌礼制药有限公司 歌礼制药有限公司是一家全价值链整合型生物技术公司，聚焦有望成为治疗代谢疾病同类最佳(best-in-class)和同类首创(first-in-class)药物的开发和商业化。利用公司专有的基于结构的AI辅助药物发现(Artificial Intelligence-assisted Structure-Based Drug Discovery，AISBDD)、超长效药物开发平台(Ultra-Long-Acting Platform，ULAP)技术以及口服多肽递送增强技术(Peptide Oral Transport ENhancement Technology，POTENT)，歌礼已自主研发多款小分子和多肽候选药物，包括其核心项目ASC30，一款在研小分子GLP-1R激动剂，既可每日一次口服也可每月一次至每季度一次皮下注射作为减重治疗疗法和减重维持疗法，用于长期体重管理；ASC36，一款胰淀素受体激动剂多肽，ASC35，一款每月一次皮下注射GLP-1R/GIPR双靶点激动剂多肽，ASC37，一款GLP-1R/GIPR/GCGR三靶点激动剂多肽，ASC39，一款类似eloralintide、对胰淀素具有选择性的强效口服小分子胰淀素受体激动剂，ASC30_39 FDC，ASC30(GLP-1RA)与ASC39(胰淀素受体激动剂)的固定剂量复方制剂(FDC)，和ASC30_48 FDC，ASC30(GLP-1RA)与ASC48(GIP RA)的固定剂量复方制剂(FDC)，用于长期体重管理。歌礼已在香港联交所上市(1672.HK)。 欲了解更多信息，敬请登录网站：www.ascletis.com。